BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCITEOSA

    MDR report key: 15741200 · Received November 6, 2022

    Report

    Report Number
    3017737771-2022-00021
    Event Type
    Injury
    Date Received
    November 6, 2022
    Date of Event
    October 7, 2022
    Report Date
    November 6, 2022
    Manufacturer
    SIGNIFIER MEDICAL TECHNOLOGIES
    Product Code
    QNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD PRE-EXISTING DENTAL WORK, AND REPORTED THIS EVENT AS PART OF A RESEARCH STUDY (B)(4). THERE IS NO VALID EVIDENCE THAT EXCITEOSA CAUSED THE EVENT. THE PATIENT HAS PRE-EXISTING DENTAL WORK, ALTHOUGH IT REMAINS UNCONFIRMED WHICH DENTAL WORK THEY HAVE AND IF IT WAS ON THE TOOTH THAT HAD THE ROOT CANAL. EXCITEOSA TARGETS THE GENIOGLOSSUS, NOT TEETH, THEREFORE SIGNIFIER MEDICAL TECHNOLOGIES LIMITED BELIEVE THE EVENT IS NOT ASSOCIATED TO EXCITEOSA. THE PATIENT STARTED THERAPY ON (B)(6) 2021, AND COMPLETED A TOTAL OF 87 THERAPIES UNTIL (B)(6) 2021. DURING THIS PERIOD, THE PATIENT REPORTED NO ADVERSE EVENTS, DISCOMFORT OR SENSITIVITY. THE DATE OF THE ROOT CANAL IS ALSO UNCONFIRMED. SIGNIFIER MEDICAL TECHNOLOGIES HAVE ATTEMPTED TO FOLLOW UP WITH THE PATIENT AND THEIR DENTIST SEVERAL TIMES, BUT THERE HAS BEEN NO RESPONSE YET. THE PATIENT IS NO LONGER USING THE DEVICE.

    Description of Event or Problem · 0

    TOOTH SENSITIVITY, DISCOMFORT AND HAD A ROOT CANAL. THE PATIENT HAD PRE-EXISTING DENTAL WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250425 EXCITEOSA EXCITEOSA QNO SIGNIFIER MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown